The Human Touch: a Patient-Centric Injection Device

Molly Story PhD

29th-Nov-2017

Description: The goal is to ensure that the device user interface has been designed such that use errors that occur during use of the device that could cause harm or degrade medical treatment are either eliminated or reduced to the extent possible.

Why should we care about being patient-centric?
•The FDA tells us:
•Our drugs must be safe and efficacious;
•Our drug delivery devices must be safe
and effective;
•And we must present the evidence in our
regulatory submissions.

What guidance has FDA published on human factors?
• Applying Human Factors and Usability Engineering
to Medical Devices (CDRH, 2016)
• “This guidance recommends that manufacturers follow human
factors or usability engineering processes during the development
of new medical devices, focusing specifically on the user
interface….
• “The goal is to ensure that the device user interface has been
designed such that use errors that occur during use of the device
that could cause harm or degrade medical treatment are either
eliminated or reduced to the extent possible.”

What international standards define HF for devices?
• IEC 62366-1:2015 (+ IEC TR 6366-2:2016), Medical devices
— Application of usability engineering to medical devices
• “This international standard describes a usability engineering process
to provide acceptable risk related to usability of a medical device….”
• “This international standard strictly focuses on applying the usability
engineering process to optimize medical device usability as it relates to
safety.”
• “The companion technical report (IEC 62366-2) is comprehensive and
has a broader focus. It focuses not only on usability as it relates to
safety, but also on how usability relates to attributes such as task
accuracy, completeness and efficiency, and user satisfaction.”

• Introduction of term and method of “Formative Evaluation”
• Addition of companion Technical Report (IEC TR 62366-2:2016)
• Provides much more guidance about how to meet the standard but also
how best to utilize a variety of human factors methods

• Timing: After product development is believed to be completed
• Goal: Ensure that the product will be safe and effective in use
• Freedom: Usually only the labeling can be changed
The Human Touch - Develop a Patient-Centric Injection Device | Molly Story - 27 September 2017

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So who are the users? And who do we test?
• Health care providers
• Specialty
• Experience and training

•The user…?
•If users can use the product well, your
product will be much more likely to be safe
and effective for the patients and other
users and to be commercially successful.
The Human Touch - Develop a Patient-Centric Injection Device | Molly Story - 27 September 2017